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NCT01857713 · ClinicalTrials.gov registry record · NA

Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

A NA study of Laryngopharyngeal Reflux, sponsored by Somna Therapeutics, L.L.C..

Completed
Registry status
NA
Development phase
95
Enrollment target
5
Study locations

NCT01857713: Completed NA study of Laryngopharyngeal Reflux, sponsored by Somna Therapeutics, L.L.C..

NCT01857713 is a NA study of Laryngopharyngeal Reflux that has completed, run by Somna Therapeutics, L.L.C.. The registered enrollment target is 95 participants, roughly in line with the 92-participant average among 3 other Laryngopharyngeal Reflux trials with a reported enrollment target. The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01857713, a NA study of Laryngopharyngeal Reflux, has completed, sponsored by Somna Therapeutics, L.L.C..

COMPLETED
Registry status
NA
Development phase
95 participants
Enrollment target
5
Study locations

Study Summary

The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

Primary Outcome

The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).

Conditions Studied

Interventions

  • DEVICE Reza Band UES Assist Device

Study Locations (5)

New York

  • Dr. Alan Raymond - New York
  • Madison ENT & Facial Plastic surgery - New York

Wisconsin

  • Wisconsin Center for Advanced Research - Milwaukee
  • Aurora Health Care - Summit

Tennessee

  • Vanderbilt University - Nashville

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2013-04
Est. Completion 2013-09
Phase NA
Somna Therapeutics, L.L.C.

1 total trials

What the finished NCT01857713 record still lists

NCT01857713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, roughly in line with the 92-participant average among 3 other Laryngopharyngeal Reflux trials with a reported enrollment target.

The record links to 1 condition, with Laryngopharyngeal Reflux appearing as the primary indexed condition, and to 1 intervention - of which Reza Band UES Assist Device is the first listed.

NCT01857713 lists 5 locations in 3 states (New York, Wisconsin, Tennessee).

Frequently Asked Questions

What is clinical trial NCT01857713 about?

NCT01857713 is a clinical study titled "Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device". The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

What is the current status of trial NCT01857713?

This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2013-04. Estimated completion is 2013-09.

What conditions does trial NCT01857713 study?

This clinical trial studies the following conditions: Laryngopharyngeal Reflux.

What interventions are being tested in trial NCT01857713?

The interventions under investigation include: Reza Band UES Assist Device (DEVICE).

Who is sponsoring clinical trial NCT01857713?

This trial is sponsored by Somna Therapeutics, L.L.C., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01857713 being conducted?

This trial has 5 study locations across New York, Tennessee, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01857713, the US trial registry maintained by the National Library of Medicine. NCT01857713 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.